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1.
Pediatr Cardiol ; 41(4): 755-763, 2020 Apr.
Article in English | MEDLINE | ID: mdl-32008060

ABSTRACT

We aimed to investigate the complications after epicardial pacemaker (PM) implantation in neonates and infants and their relationship with factors such as device size and patient size. Between May 2010 and July 2018, 55 patients under 1 year of age who underwent epicardial PM placement were retrospectively evaluated. PM-related complications requiring rehospitalization were determined as wound site problems requiring surgical intervention, battery pocket infection, battery pocket dehiscence without infection, PM removal, relocation of the PM system, and replacement of the PM system with another system. The patients were divided into three groups: < 3 kg, 3-5 kg and > 5 kg. Fifty-five patients underwent PM implantation, 43 (78.2%) because of postoperative atrioventricular block (AVB), 10 (18.2%) because of congenital AVB, and two (3.6%) with diagnoses of c-TGA and AVB. Five (9%) patients incurred 18 complications. No statistically significant difference was observed in complication development between the groups (p > 0.05). Single- or dual-chamber device implantation did not affect complication development (p > 0.05). Despite the role of factors such as low weight, low age, and device volume in the development of wound complications, the relationship between these factors and complications is not statistically significant. Therefore, our results are encouraging in terms of the use of dual-chamber PMs instead of single-chamber ones in heart diseases in which AV synchronization is important.


Subject(s)
Pacemaker, Artificial/adverse effects , Surgical Wound Dehiscence/therapy , Atrioventricular Block/surgery , Female , Follow-Up Studies , Humans , Infant , Infant, Low Birth Weight/physiology , Infant, Newborn , Male , Pacemaker, Artificial/classification , Retrospective Studies
2.
Europace ; 22(5): 833-838, 2020 05 01.
Article in English | MEDLINE | ID: mdl-32073116

ABSTRACT

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess procedural settings, safety measures, and short-term outcomes associated with implantation of leadless pacemakers (LLPM), across a broad range of tertiary European electrophysiology centres. An internet-based electronic questionnaire (30 questions) concerning implantation settings, peri-procedural routines, complications, and in-hospital patient outcomes was circulated to centres routinely implanting both LLPMs and transvenous pacemakers (TV-PM). The centres were requested to prospectively include consecutive patients implanted with either LLPMs or TV-PMs during the 10-week enrolment period. Overall, 21 centres from four countries enrolled 825 consecutive patients between November 2018 and January 2019, including 69 (9%) implanted with LLPMs. Leadless pacemakers were implanted mainly under local anaesthesia (69%), by an electrophysiologist (60%), in the electrophysiology laboratory (71%); 95% of patients received prophylactic antibiotics prior to implantation. Most patients on chronic oral anticoagulation were operated on-drug (35%), or during short-term (to 48 h) drug withdrawal (54%). Implantation was successful in 98% of patients and the only in-hospital procedure-related complication was groyne haematoma in one patient. This EHRA snapshot survey provides important insights into LLPM implantation routines and patient outcomes. These findings suggest that despite the unfavourable clinical profile of pacemaker recipients, LLPM implantation is associated with relatively low risk of complications and good short-term outcomes.


Subject(s)
Pacemaker, Artificial , Cardiac Pacing, Artificial , Feasibility Studies , Humans , Pacemaker, Artificial/classification , Prospective Studies , Surveys and Questionnaires
3.
Rev. esp. cardiol. (Ed. impr.) ; 72(11): 944-953, nov. 2019. tab, graf
Article in Spanish | IBECS | ID: ibc-190746

ABSTRACT

Introducción y objetivos: Se describe el resultado del análisis de los dispositivos de estimulación implantados y remitidos al Registro Español de Marcapasos en 2018. Métodos: Información que aporta la Tarjeta Europea del Paciente Portador de Marcapasos, así como los datos proporcionados por la industria sobre el número total de dispositivos implantados. Resultados: Se recibió información de 90 centros hospitalarios, con un total de 12.148 tarjetas, lo cual supone un 31% de la actividad total estimada. El consumo de generadores convencionales y de dispositivos de resincronización fue de 825 y 77 unidades por millón de habitantes respectivamente. La media de edad de los pacientes que recibieron un implante fue 78,3 años y un 54% de los dispositivos se implantaron en pacientes mayores de 80 años. El 77,1% de los procedimientos fueron primoimplantes y el 21,6%, recambios de generador. Aunque la estimulación secuencial bicameral sigue siendo mayoritaria, se utiliza menos en pacientes mayores de 80 años y en mujeres. Además, al 28% de los pacientes con enfermedad del nódulo sinusal y el 24,7% de aquellos con bloqueo auriculoventricular se los estimula en modo VVI/R pese a estar en ritmo sinusal. Conclusiones: El consumo total de generadores de marcapasos en España ha aumentado en un 1,2% con respecto al año 2017, fundamentalmente a expensas del aumento del consumo de generadores de terapia de resincronización cardiaca con marcapasos (8,7%). Los factores directamente relacionados con la elección del modo de estimulación son la edad y el sexo


Introduction and objectives: This report describes the result of the analysis of the implanted pacemakers reported to the Spanish Pacemaker Registry in 2018. Methods: The analysis is based on the information provided by the European Pacemaker Identification Card and supplier-reported data on the overall number of implanted pacemakers. Results: Information was received from 90 hospitals, with a total of 12 148 cards, representing 31% of the estimated activity. Use of conventional and resynchronization pacemakers was 825 and 77 units per million people, respectively. The mean age of the patients receiving an implant was 78.3 years, and 54% of the devices were implanted in people aged> 80 years. A total of 77.1% were first implants and 21.6% corresponded to generator exchanges. Bicameral sequential pacing was the most frequent pacing mode but was less frequently used in patients aged> 80 years and in women. Single chamber VVI/R pacing was used in 28% of patients with sick sinus syndrome and in 24.7% of those with atrioventricular block, despite being in sinus rhythm. Conclusions: The total consumption of pacemaker generators in Spain increased by 1.2% compared with 2017, mainly due to an 8.7% increase in cardiac resynchronization therapy with pacemaker generators. Selection of pacing mode was directly influenced by age and sex


Subject(s)
Humans , Male , Female , Aged , Aged, 80 and over , Pacemaker, Artificial/statistics & numerical data , Cardiac Pacing, Artificial/methods , Atrioventricular Block/surgery , Atrial Fibrillation/surgery , Sick Sinus Syndrome/surgery , Spain/epidemiology , Diseases Registries/statistics & numerical data , Pacemaker, Artificial/classification , Patient Selection , Atrial Fibrillation/epidemiology , Atrioventricular Block/epidemiology , Sick Sinus Syndrome/epidemiology , Wireless Technology/trends
5.
J Med Econ ; 22(11): 1171-1178, 2019 Nov.
Article in English | MEDLINE | ID: mdl-31373521

ABSTRACT

Aims: Novel leadless pacemakers (LPMs) may reduce complications and associated costs related to conventional pacemaker systems. This study sought to estimate the incidence and associated costs of traditional pacemaker complications, in those patients who were eligible for LPM implantation. Methods: A retrospective analysis was conducted on the French National Hospital Database (PMSI), including all patients implanted with a pacemaker in France in 2012, who could have alternatively received an LPM. Complication rates and their associated costs 3 years post-implantation were estimated from the perspective of the French social security system. Results: From a total of 65,553 patients, 11,770 (18%) met the inclusion criteria. Overall, 618 patients (5.3%) had a record of pacemaker complications during follow-up, of which 89% were related to the lead and pocket. Most common were pocket bleeding, lead- or generator-related mechanical complications, and pneumothorax. Overall, the mean cost of pacemaker complications per patient was €6,674 ± 3,867 at 3 years. Specifically, €7,143 ± 2,685 for pocket bleeding, €5,123 ± 2,676 for pneumothorax, and €6,020 ± 3,272 for mechanical complications. Conclusions: Major complications associated with the lead and pocket of conventional pacemaker systems are still common, and these represent a significant burden to healthcare systems as they generate substantial costs.


Subject(s)
Pacemaker, Artificial/adverse effects , Pacemaker, Artificial/economics , Adolescent , Adult , Aged , Aged, 80 and over , Child , Equipment Failure/economics , Female , France/epidemiology , Health Resources/economics , Hemorrhage/economics , Hemorrhage/etiology , Humans , Male , Middle Aged , Pacemaker, Artificial/classification , Pneumothorax/economics , Pneumothorax/etiology , Postoperative Complications/economics , Retrospective Studies , Risk Factors , Young Adult
6.
JACC Clin Electrophysiol ; 5(5): 576-586, 2019 05.
Article in English | MEDLINE | ID: mdl-31122379

ABSTRACT

OBJECTIVES: This paper reports the development, validation, and public availability of a new neural network-based system which attempts to identify the manufacturer and even the model group of a pacemaker or defibrillator from a chest radiograph. BACKGROUND: Medical staff often need to determine the model of a pacemaker or defibrillator (cardiac rhythm device) quickly and accurately. Current approaches involve comparing a device's radiographic appearance with a manual flow chart. METHODS: In this study, radiographic images of 1,676 devices, comprising 45 models from 5 manufacturers were extracted. A convolutional neural network was developed to classify the images, using a training set of 1,451 images. The testing set contained an additional 225 images consisting of 5 examples of each model. The network's ability to identify the manufacturer of a device was compared with that of cardiologists, using a published flowchart. RESULTS: The neural network was 99.6% (95% confidence interval [CI]: 97.5% to 100.0%) accurate in identifying the manufacturer of a device from a radiograph and 96.4% (95% CI: 93.1% to 98.5%) accurate in identifying the model group. Among 5 cardiologists who used the flowchart, median identification of manufacturer accuracy was 72.0% (range 62.2% to 88.9%), and model group identification was not possible. The network's ability to identify the manufacturer of the devices was significantly superior to that of all the cardiologists (p < 0.0001 compared with the median human identification; p < 0.0001 compared with the best human identification). CONCLUSIONS: A neural network can accurately identify the manufacturer and even model group of a cardiac rhythm device from a radiograph and exceeds human performance. This system may speed up the diagnosis and treatment of patients with cardiac rhythm devices, and it is publicly accessible online.


Subject(s)
Image Processing, Computer-Assisted/methods , Neural Networks, Computer , Pacemaker, Artificial/classification , Thorax/diagnostic imaging , Databases, Factual , Humans , Radiography, Thoracic
7.
J Cardiovasc Med (Hagerstown) ; 19(4): 161-169, 2018 04.
Article in English | MEDLINE | ID: mdl-29470250

ABSTRACT

: Modern pacemakers have an increasing number of programable parameters and specific algorithms designed to optimize pacing therapy in relation to the individual characteristics of patients. When choosing the most appropriate pacemaker type and programing, the following variables must be taken into account: the type of bradyarrhythmia at the time of pacemaker implantation; the cardiac chamber requiring pacing, and the percentage of pacing actually needed to correct the rhythm disorder; the possible association of multiple rhythm disturbances and conduction diseases; the evolution of conduction disorders during follow-up. The goals of device programing are to preserve or restore the heart rate response to metabolic and hemodynamic demands; to maintain physiological conduction; to maximize device longevity; to detect, prevent, and treat atrial arrhythmia. In patients with sinus node disease, the optimal pacing mode is DDDR. Based on all the available evidence, in this setting, we consider appropriate the activation of the following algorithms: rate responsive function in patients with chronotropic incompetence; algorithms to maximize intrinsic atrioventricular conduction in the absence of atrioventricular blocks; mode-switch algorithms; algorithms for autoadaptive management of the atrial pacing output; algorithms for the prevention and treatment of atrial tachyarrhythmias in the subgroup of patients with atrial tachyarrhythmias/atrial fibrillation. The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features.


Subject(s)
Bradycardia/therapy , Cardiac Pacing, Artificial/standards , Pacemaker, Artificial/classification , Sick Sinus Syndrome/complications , Algorithms , Atrial Fibrillation/prevention & control , Atrial Fibrillation/therapy , Consensus , Hemodynamics , Humans , Italy , Societies, Medical , Tachycardia/prevention & control , Tachycardia/therapy
8.
J Cardiovasc Med (Hagerstown) ; 19(4): 170-180, 2018 04.
Article in English | MEDLINE | ID: mdl-29470251

ABSTRACT

: The purpose of this two-part consensus document is to provide specific suggestions (based on an extensive literature review) on appropriate pacemaker setting in relation to patients' clinical features. In part 2, criteria for pacemaker choice and programming in atrioventricular blocks and neurally mediate syncope are proposed. The atrioventricular blocks can be paroxysmal or persistent, isolated or associated with sinus node disease. Neurally mediated syncope can be related to carotid sinus syndrome or cardioinhibitory vasovagal syncope. In sinus rhythm, with persistent atrioventricular block, we considered appropriate the activation of mode-switch algorithms, and algorithms for auto-adaptive management of the ventricular pacing output. If the atrioventricular block is paroxysmal, in addition to algorithms mentioned above, algorithms to maximize intrinsic atrioventricular conduction should be activated. When sinus node disease is associated with atrioventricular block, the activation of rate-responsive function in patients with chronotropic incompetence is appropriate. In permanent atrial fibrillation with atrioventricular block, algorithms for auto-adaptive management of the ventricular pacing output should be activated. If the atrioventricular block is persistent, the activation of rate-responsive function is appropriate. In carotid sinus syndrome, adequate rate hysteresis should be programmed. In vasovagal syncope, specialized sensing and pacing algorithms designed for reflex syncope prevention should be activated.


Subject(s)
Atrioventricular Block/complications , Bradycardia/therapy , Cardiac Pacing, Artificial/standards , Pacemaker, Artificial/classification , Syncope, Vasovagal/complications , Algorithms , Atrial Fibrillation/prevention & control , Atrial Fibrillation/therapy , Consensus , Hemodynamics , Humans , Italy , Sick Sinus Syndrome/complications , Societies, Medical
9.
J Am Coll Cardiol ; 69(2): 189-210, 2017 Jan 17.
Article in English | MEDLINE | ID: mdl-28081829

ABSTRACT

Advances in cardiac surgery toward the mid-20th century created a need for an artificial means of stimulating the heart muscle. Initially developed as large external devices, technological advances resulted in miniaturization of electronic circuitry and eventually the development of totally implantable devices. These advances continue to date, with the recent introduction of leadless pacemakers. In this first part of a 2-part review, we describe indications, implant-related complications, basic function/programming, common pacemaker-related issues, and remote monitoring, which are relevant to the practicing cardiologist. We provide an overview of magnetic resonance imaging and perioperative management among patients with cardiac pacemakers.


Subject(s)
Pacemaker, Artificial , Prosthesis Failure , Atrial Fibrillation/therapy , Bradycardia/therapy , Cardiac Resynchronization Therapy Devices/classification , Electrocardiography , Humans , Pacemaker, Artificial/classification , Prosthesis Design , Signal Processing, Computer-Assisted , Software
10.
J Invasive Cardiol ; 28(12): E198-E202, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27922811

ABSTRACT

OBJECTIVES: The purpose of this study was to determine if implantation of multiple recalled defibrillator leads is associated with an increased risk of lead failure. BACKGROUND: The authors of the Pacemaker and Implantable Defibrillator Leads Survival Study ("PAIDLESS") have previously reported a relationship between recalled lead status, lead failure, and patient mortality. This substudy analyzes the relationship in a smaller subset of patients who received more than one recalled lead. The specific effects of having one or more recalled leads have not been previously examined. METHODS: This study analyzed lead failure and mortality of 3802 patients in PAIDLESS and compared outcomes with respect to the number of recalled leads received. PAIDLESS includes all patients at Winthrop University Hospital who underwent defibrillator lead implantation between February 1, 1996 and December 31, 2011. Patients with no recalled ICD leads, one recalled ICD lead, and two recalled ICD leads were compared using the Kaplan-Meier method and log-rank test. Sidak adjustment method was used to correct for multiple comparisons. All calculations were performed using SAS 9.4. P-values <.05 were considered statistically significant. RESULTS: This study included 4078 total ICD leads implanted during the trial period. There were 2400 leads (59%) in the no recalled leads category, 1620 leads (40%) in the one recalled lead category, and 58 leads (1%) in the two recalled leads category. No patient received more than two recalled leads. Of the leads categorized in the two recalled leads group, 12 experienced lead failures (21%), which was significantly higher (P<.001) than in the no recalled leads group (60 failures, 2.5%) and one recalled lead group (81 failures; 5%). Multivariable Cox's regression analysis found a total of six significant predictive variables for lead failure including the number of recalled leads (P<.001 for one and two recalled leads group). CONCLUSIONS: The number of recalled leads is highly predictive of lead failure. Lead-based multivariable Cox's regression analysis produced a total of six predictive variable categories for lead failure, one of which was the number of recalled leads. Kaplan-Meier analysis showed that the leads in the two recalled leads category failed faster than both the no recalled lead and one recalled lead groups. The greater the number of recalled leads to which patients are exposed, the greater the risk of lead failure.


Subject(s)
Defibrillators, Implantable , Electric Countershock , Equipment Failure/statistics & numerical data , Medical Device Recalls , Pacemaker, Artificial , Aged , Defibrillators, Implantable/adverse effects , Defibrillators, Implantable/classification , Defibrillators, Implantable/statistics & numerical data , Electric Countershock/adverse effects , Electric Countershock/instrumentation , Electric Countershock/methods , Equipment Design , Equipment Failure Analysis/methods , Equipment Failure Analysis/statistics & numerical data , Female , Heart Diseases/therapy , Humans , Male , Middle Aged , Pacemaker, Artificial/adverse effects , Pacemaker, Artificial/classification , Pacemaker, Artificial/statistics & numerical data , United States
11.
J Emerg Med ; 51(5): 584-588, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27618475

ABSTRACT

BACKGROUND: As the incidence of left bundle branch blocks (LBBBs) and paced-rhythms electrocardiograms (ECGs) increase in the aging global population, the need for rapid and accurate diagnosis of ST-elevation myocardial infarction (STEMI) or STEMI equivalents in patients with these rhythms becomes more imperative. The Sgarbossa and Smith-modified Sgarbossa criteria have been documented to enhance the diagnosis of STEMI in the setting of LBBBs. However, there is a growing body of literature that suggests that these criteria can also be applied for the diagnosis of STEMI in patients with paced rhythms. CASE REPORT: We present the case of an 84-year old man who was on admission for cellulitis when he developed acute respiratory distress. An ECG revealed findings that were consistent with positive Smith-modified Sgarbossa criteria, upon which the diagnosis of STEMI was made. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Although the sensitivity and specificity of these criteria in paced rhythms is not well documented, if a patient meets these criteria in an appropriate clinical setting, cardiac catheterization laboratory activation by an emergency physician could be appropriate.


Subject(s)
Bundle-Branch Block/classification , Decision Support Techniques , Electrocardiography/methods , Pacemaker, Artificial/classification , ST Elevation Myocardial Infarction/diagnosis , Aged, 80 and over , Humans , Male , Reproducibility of Results , Sensitivity and Specificity
12.
Europace ; 18(5): 778-84, 2016 May.
Article in English | MEDLINE | ID: mdl-27226497

ABSTRACT

The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly less frequent in patients treated with NOACs. Despite this, the incidence of severe pocket haematomas was low.


Subject(s)
Anticoagulants/administration & dosage , Defibrillators, Implantable/adverse effects , Hematoma/epidemiology , Pacemaker, Artificial/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Europe , Female , Hematoma/etiology , Hemorrhage/chemically induced , Humans , Male , Middle Aged , Pacemaker, Artificial/classification , Perioperative Period , Postoperative Complications/epidemiology , Prospective Studies , Reoperation , Surveys and Questionnaires , Young Adult
13.
Fed Regist ; 81(74): 22525-30, 2016 Apr 18.
Article in English | MEDLINE | ID: mdl-27101641

ABSTRACT

The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.


Subject(s)
Cardiac Resynchronization Therapy Devices/classification , Pacemaker, Artificial/classification , Device Approval/legislation & jurisprudence , Equipment Safety/classification , Humans , United States
14.
Heart Rhythm ; 13(6): 1253-9, 2016 06.
Article in English | MEDLINE | ID: mdl-26829114

ABSTRACT

BACKGROUND: The Medtronic model 4195 (StarFix) left ventricular lead is an active fixation lead that provides additional support within the coronary sinus (CS) via deployable lobes. While this lead has been shown to have excellent stability within the CS, concerns about its extractability have been raised. OBJECTIVE: The aim of this study was to compare the safety and efficacy of the extraction of the model 4195 lead vs other Medtronic CS leads in a prospective cohort study. METHODS: Patients undergoing extraction of this and other CS leads for standard indications were prospectively enrolled and studied. The primary outcomes of interest were the removal success rates and associated complication rates. Patients were followed for a month postprocedure. RESULTS: The overall left ventricular lead extraction success rate was 97.6% (n = 205). Among 40 patients with chronic model 4195 leads, there were 37 successful extractions (92.5%) as compared to 98.8% for the 165 non-4195 leads. However, in 2 of the 3 StarFix lead extraction failures, standard extraction techniques were not used. All 10 of the model 4195 leads that had been implanted for less than 6 months were extracted without incident. CONCLUSION: In this largest study of CS lead extractions published to date, the overall success rate of the extraction of chronically implanted CS leads is high and the complication rate is similar in these lead models. The extraction of the model 4195 lead is clearly more challenging, but it can be accomplished in high-volume extraction centers with experienced operators. It is recommended that the model 4195 lead be extracted by experienced operators.


Subject(s)
Cardiac Resynchronization Therapy Devices/classification , Device Removal , Intraoperative Complications , Pacemaker, Artificial/classification , Aged , Cohort Studies , Coronary Sinus/surgery , Device Removal/adverse effects , Device Removal/methods , Equipment Design , Female , Humans , Intraoperative Complications/epidemiology , Intraoperative Complications/etiology , Male , Middle Aged , Outcome and Process Assessment, Health Care , Prospective Studies
15.
Cardiol Young ; 26(6): 1066-71, 2016 Aug.
Article in English | MEDLINE | ID: mdl-26796814

ABSTRACT

At present, there are many pacing strategies for young patients with complete atrioventricular block. The most frequent policy is to attempt placing a dual-chamber system when possible; however, there is a group of patients that is functioning with a non-synchronous ventricular pacing, raising the question of the ideal timing to upgrade their systems. We investigated the exercise performance of a group of children and young adults with complete atrioventricular block and dual-chamber pacemakers in both single- and dual-chamber pacing modalities. A total of 15 patients performed maximal exercise stress testing after programming the VVIR or DDD modes with 2 hours of interval in a double-blind study protocol. Compared with VVIR pacing, DDD pacing resulted in increase in the peak VO2, longer test duration, major increase in the heart rate achieved during peak exercise, decreased systemic non-invasive arterial blood pressure measured at maximal exercise, higher maximal workload, prolongation of the anaerobic threshold timing, and better self-rated performance perception in all the patients. Synchronous atrioventricular pacing contributes to an increase in both the exercise performance and the performance perception in 100% of the patients. This difference contributes to create a sense of "fitness" with repercussions in the overall health, self-esteem, and life quality, as well as encourages youngster to practice sports. Our experience tends to favour upgrading patients' systems to dual-chamber systems before reaching the adolescent years, even if the centre policy is to prolong as long as possible the epicardial site in order to avoid long years of right ventricular pacing.


Subject(s)
Atrioventricular Block/therapy , Cardiac Pacing, Artificial/methods , Exercise Tolerance , Pacemaker, Artificial/classification , Adolescent , Adult , Child , Double-Blind Method , Exercise Test , Female , Heart Rate , Humans , Male , Quality of Life , Young Adult
16.
Europace ; 18(5): 739-46, 2016 May.
Article in English | MEDLINE | ID: mdl-26612882

ABSTRACT

AIMS: This ANSWER (EvaluAtioN of the SafeR mode in patients With a dual chambER pacemaker indication) sub-study assesses safety and effectiveness of SafeR™ and the impact of ventricular pacing (VP) prevention on anticipated device longevity and replacement rate. METHODS AND RESULTS: Patients implanted for atrioventricular block (AVB, n = 310) or sinus node dysfunction (SND, n = 336) were randomly assigned to SafeR (n = 314) or DDD (n = 318) and followed for 36 months. Safety, median VP, estimated device longevity (mean difference, 95% confidence interval [CI]), and anticipated replacement rates were analysed by pacing mode and implant indication. No difference in mortality, syncope, or mode intolerance was observed between randomization groups regardless of the indication. Ventricular pacing on SafeR vs. DDD was 11.5 vs. 93.6% in the overall population (P < 0.001), 89.2 vs. 83.8% in permanent AVB (P = 0.944), 53.5 vs. 98.2% in intermittent AVB (P < 0.001), and 2.2 vs. 84.7% in SND (P < 0.001). Anticipated median device longevity increased on SafeR by 14 [Q1 10; Q3 17] months [10; 17] (P < 0.001) in the overall population, 9 months [-5; 22] (P = 0.193) in permanent AVB, 14 months [8; 19] (P < 0.001) in intermittent AVB, and 14 months [9; 19] (P < 0.001) in SND. In intermittent AVB and SND, prolonged estimated battery longevity translated into the prevention of one anticipated replacement in at least 23% of patients. CONCLUSION: SafeR was effective in reducing VP in intermittent AVB and in SND. No effect was observed in permanent AVB. No safety issue was observed. Ventricular pacing reduction by SafeR translated into relevant estimated prolongation of device longevity and anticipated reduction of required replacements.


Subject(s)
Atrioventricular Block/therapy , Cardiac Pacing, Artificial/methods , Equipment Design/methods , Pacemaker, Artificial/adverse effects , Sick Sinus Syndrome/therapy , Aged , Aged, 80 and over , Cardiac Pacing, Artificial/adverse effects , Electric Power Supplies , Europe , Female , Heart Ventricles/physiopathology , Humans , Male , Middle Aged , Pacemaker, Artificial/classification , Prospective Studies , Single-Blind Method , Treatment Outcome
18.
Harefuah ; 154(5): 288-91, 340, 2015 May.
Article in Hebrew | MEDLINE | ID: mdl-26168636

ABSTRACT

AIMS: To review the changes in permanent pacemaker implantation indications, pacing modes and patients' demographics over a 20-year period. METHODS AND RESULTS: We retrospectively retrieved data on patients who underwent first implantation of the pacemaker between 1-1-1991 and 31-12-2010. One thousand and nine (1,009) patients underwent a first pacemaker implantation during that period; 535 were men (53%), their mean age was 74.6±19.5 years; the highest rate of implanted pacemaker was in patients ranging in age from 70-79 years, however there was an increasing number of patients aged over 80 years. The median survival time after initial pacemaker implantation was 8 years. Syncope was the most common symptom (62.5%) and atrioventricular block was the most common electrocardiographic indication (56.4%) leading to pacemaker implantation. There was increased utilization of dual chamber and rate responsive pacemakers over the years. There was no difference regarding mode selection between genders. CONCLUSIONS: Pacemaker implantation rates have increased over a 20-year period. Dual chamber replaced most of the single ventricular chamber pacemaker and rate responsive pacemakers became the norm. The data of a small volume center are similar to those reported in pacemaker surveys of high volume pacemaker implantation centers. They confirm adherence to the published guidelines for pacing.


Subject(s)
Atrioventricular Block , Cardiac Pacing, Artificial , Aged , Aged, 80 and over , Atrioventricular Block/complications , Atrioventricular Block/epidemiology , Atrioventricular Block/therapy , Cardiac Pacing, Artificial/methods , Cardiac Pacing, Artificial/statistics & numerical data , Female , Humans , Israel/epidemiology , Male , Outcome Assessment, Health Care , Pacemaker, Artificial/classification , Pacemaker, Artificial/statistics & numerical data , Retrospective Studies , Syncope/etiology , Syncope/therapy
19.
Med. clín (Ed. impr.) ; 144(12): 550-552, jun. 2015. ilus
Article in Spanish | IBECS | ID: ibc-141031

ABSTRACT

Fundamento y objetivo: La insuficiencia tricuspídea (IT) grave secundaria a interferencia del cable del marcapasos (MCP) es una causa infrecuente de insuficiencia cardiaca (IC) derecha progresiva, que puede complicar la evolución del paciente. Material y métodos: Presentamos 3 casos clínicos de IC derecha secundaria a IT tras implantación de MCP. Resultados: En estos pacientes la clínica consiste en IC derecha, que puede aparecer de forma precoz, como en nuestra segunda paciente, o al cabo de años de la implantación del MCP, como en el primer y la tercera pacientes. El diagnóstico se confirma por ecocardiografía, siendo la más precisa la 3D, seguida de la transesofágica. La 2D transtorácica puede no detectarla, ya que tiene baja sensibilidad para la IT asociada a MCP. El tratamiento médico es siempre la primera opción, ya que cualquier otro procedimiento conlleva una morbimortalidad significativa. Conclusiones: Probablemente, esta es una patología que vamos a diagnosticar cada vez con más frecuencia, ya que cada vez hay más pacientes con dispositivos y, al mismo tiempo, están mejorando las herramientas diagnósticas (AU)


Conclusions: Severe tricuspid regurgitation (TR) secondary to interference pacemaker (PM) cable is a rare cause of progressive right heart failure (HF), which can worsen patient outcomes. This continuation/maintenance electroconvulsive therapy programme has shown to be clinically useful and to have a favourable economic impact, as well as high perceived quality. Introducción: We present 3 clinical cases of right HF secondary to TR after PM implantation. La terapia electroconvulsiva de continuación/mantenimiento ha demostrado su eficacia en la prevención de recaídas tanto en cuadros afectivos como psicóticos. Sin embargo, existen pocos estudios sobre variables de gestión clínica, costes asociados y calidad percibida. Results: In these patients the clinic is right HF, which can appear early, as in our second patient, or after years of implementation of the PM, as in the first and third patients. The diagnosis is confirmed by echocardiography, the most accurate 3D, followed by transesophageal. The 2D transthoracic can not detect it, because it has low sensitivity for TR associated with PM. Medical treatment is always the first choice, since any other procedure carries significant morbidity and mortality. Resultados: Probably this is a condition that we will diagnose with increasing frequency, because there are more and more patients with devices and, at the same time, the diagnostic tools are improving. Tras su inclusión en el programa, el 50,0% de los pacientes refirió encontrarse «mucho mejor», y el 37,5% «moderadamente mejor» en la Escala de Impresión Clínica Global-Mejoría Global. Además, una vez incluidos en el programa de terapia electroconvulsiva de continuación/mantenimiento, los pacientes tuvieron un total de 349 días de ingreso, 3 visitas a Urgencias y 2 ingresos urgentes, frente a los 690 días de ingreso (p = 0,012), 26 visitas a Urgencias (p = 0,011) y 22 ingresos urgentes (p = 0,010) en el mismo periodo, antes de su inclusión en el programa. Los costes directos asociados por estancia/día tras su inclusión en el programa se redujeron al 50,6% del coste previo, y los costes asociados a visitas a Urgencias disminuyeron al 11,5% del coste previo. Respecto a la calidad percibida, un 87,5% de los pacientes evaluaron la atención y tratamiento recibido como «muy satisfactorio», y un 12,5% como «satisfactorio» (AU)


Subject(s)
Female , Humans , Male , Heart Failure/congenital , Heart Failure/metabolism , Pacemaker, Artificial/supply & distribution , Pacemaker, Artificial , Pleural Effusion/blood , Pleural Effusion/genetics , Therapeutics/instrumentation , Therapeutics/nursing , Pharmaceutical Preparations/administration & dosage , Heart Failure/genetics , Heart Failure/pathology , Pacemaker, Artificial/classification , Pacemaker, Artificial/standards , Pleural Effusion/metabolism , Pleural Effusion/pathology , Therapeutics/methods , Therapeutics , Pharmaceutical Preparations
20.
Eur J Oral Sci ; 123(3): 194-201, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25913780

ABSTRACT

Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer.


Subject(s)
Defibrillators, Implantable , Dental Equipment , Electrical Equipment and Supplies , Equipment Safety , Pacemaker, Artificial , Bone-Implant Interface/anatomy & histology , Defibrillators, Implantable/classification , Dental Implantation, Endosseous/instrumentation , Dental Pulp Cavity/anatomy & histology , Dental Pulp Test/instrumentation , Dental Scaling/instrumentation , Electromagnetic Fields , Electrosurgery/instrumentation , Equipment Failure , Humans , Materials Testing , Models, Anatomic , Odontometry/instrumentation , Pacemaker, Artificial/classification , Root Canal Preparation/instrumentation , Time Factors , Tooth Apex/anatomy & histology , Ultrasonic Therapy/instrumentation
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